Devices and methods for preventing incisional hernias

ABSTRACT

A reinforcement device comprises a sheet of biocompatible material equipped with a plurality of hooks for reinforcing the closure of a surgical incision, including elongated abdominal incisions. The reinforcement device, when implanted through surgery, reduces the likelihood of and/or prevents incisional hernias. The reinforcement device may be included in a surgical kit.

TECHNICAL FIELD

This disclosure relates to medical devices, kits, and methods forreinforcing incision closures. Such devices, kits and methods may reducethe likelihood of incisional hernias.

BACKGROUND

Incisional hernias are detectable defects in a surgical site followingthe creation of a surgical incision. Such hernias may become apparent asa palpable defect; that is, abdominal contents may protrude beyond wherethey should and therefore can be physical felt. In some instances,incisional hernias may present merely as a protrusion within a healedincision.

Incisional hernias following surgery are a common complication followingcertain surgeries, including but not limited to a laparotomy. Alaparotomy is a surgical procedure involving a incision through theabdominal wall to gain access into the abdominal cavity. There arenumerous reasons why a particular patient might suffer from anincisional hernia following a laparotomy or other surgery. Patientssuffering from obesity, diabetes, or malnutrition may be moresusceptible to an incisional hernia. A patient may have poor tissue, oran infection at the incision site, making him or her more susceptible.In other instances, a closure of an incision may not be sufficientlystrong to guard against incisional hernias. An unfortunate result isthat incisional hernias are not particularly rare. In fact, following alaparotomy, the incidence of incisional hernia has ranged from 15-40%.

The incidence of incisional hernias is serious. Correction usually callsfor surgical intervention, re-operation, and/or prolongedhospitalization. Incisional hernias also may increase morbidity andmortality. In other words, the costs to the health care system and thepatient are significant, fiscally and otherwise.

It is desirable to reduce the incidence of incisional hernias, or toprevent them during an initial operation, by reinforcing surgicalclosures using medical devices, kits and/or methods.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top view an exemplary reinforcement device;

FIG. 2 is perspective view of an exemplary reinforcement device;

FIG. 3 is a top view of an exemplary reinforcement device in connectionwith an abdomen of a patient;

FIG. 4 is a perspective view of suture connecting an exemplaryreinforcement device to a patient through a plurality of hooks.

FIG. 5 is a perspective view of suture connecting an exemplaryreinforcement device to a patient through a plurality of hooks.

DETAILED DESCRIPTION

Multiple embodiments of the disclosed devices, kits and methods aredescribed with reference to only a few exemplary drawings. Although aparticular embodiment may be illustrated and described herein asincluding particular components in a particular configuration, suchcomponents and configuration are for exemplary purposes only. Thefigures and descriptions of the embodiments described herein are notintended to limit the breadth or the scope of the inventive concepts orthe appended claims. Rather, the figures and detailed descriptions areprovided to illustrate the inventive concepts to a person of ordinaryskill in the art and to enable such person to make and use the inventiveconcepts.

With reference to FIGS. 1-2, exemplary reinforcement device 10 is shown.Reinforcement device 10 comprises a sheet of biocompatible materialwhich is exemplified as mesh sheet 12. The biocompatible material may bebioabsorbable, non-bioabsorbable, partially bioabsorbable, or somecombination of one or more of these. The biocompatible material maycomprise any of a number of materials. By way of non-limiting examples,bioabsorbable materials may comprise polyhydroxy acids, polylactides,polyglycolides, polyhydroybutyrates, polyhydroxyvaleriates,polycaprolactones, polydioxanones, synthetic and natural oligo- andpolyaminoacids, polyphosphazenes, polyanhydrides, polyorthoesters,polyphosphates, polyphosphonates, polyalcohols, polysaccharides, andpolyethers. By way of non-limiting examples, mon-bioabsorbable materialsmay comprise polyalkenes, polyethylene, fluorinated polyolefins,polytetrafluoroethylene, polyvinylidenefluoride, polyamides,polyurethanes, polyisoprenes, polystryrenes, polysilicones,polycarbonates, polyaryletherketones, polymetacrylates, polyacrylates,aromatic polyesters, and polyimides.

Mesh sheet 12 may comprise a single layer of material, or it maycomprise two or more layers of material. Separate layers of material mayor may not be co-extensive in length and/or width. Mesh sheet 12 may beat least partially woven or knitted. Mesh sheet 12 have a reinforcingmaterial 14 in or on at least a portion of the mesh sheet 12.Reinforcing material may comprise any of a number of biocompatiblematerials, including but not limited to synthetic composite materialssuch as polyglactin and/or poly p-dioxane undyed yarn. The reinforcingmaterial can be applied to the mesh sheet 12 using any of a number ofimpregnating or application techniques. Reinforcing material 14 may bein the form of ribs or strips on at least a portion of the periphery ofmesh sheet 12. Reinforcing material 14 may also be applied in thehorizontal direction as a plurality of spaced apart rows. Although thestrips of reinforcing material depicted in the drawings run the entireperiphery of the reinforcing device 10 and include a plurality of spacedapart rows at a common length distance between adjacent rows, otherconfigurations are contemplated.

Mesh sheet 12 also is equipped with two or more columns of hooks 16 a,16 b that run parallel or substantially parallel to a longitudinal axisL of reinforcement device 10. The hooks depicted are shaped likeinverted U's, which are similar to wickets used in croquet. Other shapesand configurations of hooks are contemplated; the hooks are structuresthough which suture may pass in sewing the reinforcement device 10 tothe patient. These hooks 16 a, 16 b may be integrally formed with themesh sheet 12 or added on or to the mesh sheet 12 using any of a numberof methods. In the depicted embodiment, the common longitudinal distancebetween hooks within a spaced apart column is d1.

One or more of hooks 16 a, 16 b may also be affiliated with an aperture17 a, 17 b. In the depicted embodiment, each of hooks 16 a, 16 b isaffiliated with an aperture 17 a, 17 b. The apertures 17 a, 17 b aresized and shaped so that a marking end of a marking device may mark apatient's fascia where a needle and suture are to pierce a patient'sfascia to attach the reinforcement device 10 to the patient. The abilityto mark fascia may provide guidance in the form of a template to asurgeon for precision of location in a suturing process. Placement ofapertures 17 a and 17 b is sufficiently distant from an incision pointto avoid wound dehiscence.

In the depicted embodiment of FIGS. 1 and 2, the column with hooks 16 aand the column with hooks 16 b are on opposite sides of a longitudinalcenter region 18 that is substantially rectangular and encompassescenter line 18′. Center region 18 falls between the spaced apart columnsof hooks. Center region 18 extends from opposite ends of the mesh sheet12, top edge to bottom edge. The top edge and bottom edge are oppositeeach other and are perpendicular to or substantially perpendicular tothe longitudinal axis of mesh sheet 12. Within this center region 18,there is a reinforcing column of hooks 20. Hooks 20 may be of the sameor a different material and/or configuration than the hooks 16 a, 16 b.Hooks 20 may be supported by reinforcing material 14. The longitudinaldistance between hooks 20 is d2. In the depicted embodiment, d2 isgreater than d1. Different configurations and variations between thelength d1 and d2 are contemplated. For example, d2 may be 1.5× greater,2× greater, 2.5× greater, 3× greater, 3.5× greater or 4× greater thand1. Different ratios may also be suitable.

Generally, reinforcement devices 10 may have a number of shapes anddimensions. In one non-limiting exemplary embodiment of a rectangularreinforcement device 10, a horizontal width of mesh sheet 12 is about 5cm, a longitudinal length is about 15 cm or about 30 cm, d1 is about 1cm, and d2 is about 3 cm. The length of reinforcement device 10 dependsupon the length of incision, and a surgeon may cut a commerciallyavailable reinforcement device 10 to fit the size of a particularincision. The about 5 cm width overlap of the incision may add tensilestrength to the wound to assist in reducing the incidence of incisionalhernias. Generally, for about every 1 cm of d1 required to close aparticular incision, about 4 cm of suture may be used. Stated anotherway, an exemplary ratio of suture length to wound length of 4 is oneembodiment suited for prevention or reduction of incidence of incisionalhernias. Different dimensions and different ratios are contemplated;those identified in this paragraph are merely exemplary teachings.

Referring to FIGS. 3-5, examples are shown where a reinforcement device10 is used in connection with the closing of an abdominal incision. Thesurgeon places the reinforcement device 10 over the fascia, attemptingto align the center region 18, and the center line 18′ with the incisionitself. The surgeon may then mark a patient's fascia through theapertures 17 a and 17 b to indicate where the needle and suture are topierce fascia to sew the reinforcement device 10 to the patient. In onenon-limiting embodiment, the apertures 17 a and 17 b are about 1 cm inhorizontal distance from the center line 18′.

The particular suture 22 and/or needle(s) (not shown) for use with thereinforcement device 10 may be provided in a surgical kit including thereinforcement device 10, along with other medicaments, sterilizers,marking devices, cutting tools, and other medical devices and equipment.Any of a number of commercially available sutures 22 may be used withthe reinforcement device 10. The suture 22 may, for example, bebioabsorbable or non-bioabsorbable.

When the fascia is marked, a surgeon may position reinforcement device10 in a position to commence suturing. Such position may beintra-peritoneal or extra-peritoneal, depending upon the materials ofthe reinforcement device 10. For example, non-bioabsorbable materialsmay be positioned to avoid potential for adhesion to internal organs.Generally, the suturing involves inserting the sutures 22 through thefascia, then looping the suture through hooks 16 a to fascia to 16 b tofascia to 16 a to fascia to 16 b, etc. in a series of generally Z-shapedformations or a series of generally X-shaped formations, possibly usinga double needled suturing technique. Eventually, as a suturing patternencounters a hook 20 in its general path, the surgeon may gainadditional reinforcement by passing the suture 22 at least once throughand/or around hook 20 before completing the connection between a hook 16a and a hook 16 b. An exemplary non-limiting suturing pattern isindicated in FIG. 4, and another in FIG. 5. Other suturing patterns arecontemplated.

With regard to the devices, kits, methods, etc. described herein, itshould be understood that, although the steps of such methods, etc. havebeen described as occurring according to a certain ordered sequence,such methods could be practiced in an order other than the orderdescribed. It should also be understood that certain steps could beperformed simultaneously, that other steps could be added, or thatcertain steps could be omitted.

The above description is intended to be illustrative, not restrictive.The scope of the invention should be determined with reference to theappended claims along with the full scope of equivalents. It isanticipated and intended that future developments will occur in the art,and that the disclosed devices, kits and methods will be incorporatedinto such future embodiments. Thus, the invention is capable ofmodification and variation and is limited only by the following claims.

What is claimed as new and desired to be protected by Letters Patent ofthe United States is:
 1. A method of reinforcing a closure of a surgicalopening, comprising: placing a surgical mesh intra-peritoneally orextra-peritoneally such that the center region is generally aligned withan incision, wherein the surgical mesh has a longitudinal axis and ahorizontal axis and a plurality of spaced apart columns of hooks on thesurgical mesh running substantially parallel to one another andsubstantially parallel with the longitudinal axis, the hooks in eachcolumn having a common longitudinal distance between each adjacent hook;and a reinforcing column of hooks on the surgical mesh between thespaced apart columns of hooks, wherein the hooks in the reinforcingcolumn have a greater common longitudinal distance between hooks than inthe spaced apart columns of hooks; wherein the plurality of spaced apartcolumns comprises a first column on a first side of an center region andthe second column on a second side of the center region, wherein thecenter region is an elongated substantially rectangular area thatextends from a first edge of the sheet to a second edge of the sheet,the first and second edges being opposite one another and beingsubstantially perpendicular to the longitudinal axis of the sheet;suturing the surgical mesh to fascia, and looping suture through hooksin the spaced apart columns in a series of shaped formations; and when ahook in the reinforcing column falls within a single shaped formation,winding suture through such hook in the reinforcing column.
 2. Themethod of claim 1 further comprising, prior to suturing, marking suturepoints on human tissue through a plurality of the apertures.
 3. A methodof preventing an abdominal incisional hernia, comprising: placingsurgical mesh intra-peritoneally or extra-peritoneally in an abdomensuch that the center region is aligned with an incision; wherein thesurgical mesh has a longitudinal axis and a horizontal axis and aplurality of spaced apart columns of hooks on the surgical mesh runningsubstantially parallel to one another and substantially parallel withthe longitudinal axis, the hooks in each column having a commonlongitudinal distance between each adjacent hook; and a reinforcingcolumn of hooks on the surgical mesh between the spaced apart columns ofhooks, wherein the hooks in the reinforcing column have a greater commonlongitudinal distance between hooks than in the spaced apart columns ofhooks; wherein the plurality of spaced apart columns comprises a firstcolumn on a first side of an center region and the second column on asecond side of the center region, wherein the center region is anelongated substantially rectangular area that extends from a first edgeof the sheet to a second edge of the sheet, the first and second edgesbeing opposite one another and being substantially perpendicular to thelongitudinal axis of the sheet; suturing the surgical mesh to fascia byinserting suture through fascia and through hooks in the spaced apartcolumns in a series of substantially Z-shaped or X-shaped formationssuch that a ratio of suture length to incision length is about 4:1; andwhen a hook in the reinforcing column falls within a specific Z-shapedor X-shaped formation, looping the suture through such hook in thereinforcing column.